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Business
Beloit's NorthStar ramps into moly-99 market

BELOIT

NorthStar Medical Radioisotopes CEO George Messina showed off a conversation piece he keeps in his office at the company’s Beloit headquarters: A coin-shaped molybdenum “target”—a small disc similar to the kind NorthStar zaps with neutrons in a Missouri nuclear reactor to make the medical isotope molybdenum-99.

The molybdenum target was light gray, and because it had never been used in any nuclear reaction, Messina said, it was as safe to handle “as a garden rock.” The disc felt dense and heavy, even though it was small—about the size of a golf ball marker.

“If you put it in a reactor for a week, you’d have one heck of an expensive golf ball marker,” Messina joked.

Indeed.

NorthStar earlier this month received federal regulatory drug approval, which the company said will make it the first domestic, private company in a quarter century to actively produce and supply the medical imaging isotope molybdenum-99 and its active isotope, technetium-99m, in the U.S.

In cracking into the medical moly-99 market, NorthStar believes that within a year it could supply as much as 10 percent of moly-99 and technetium-99m in the nation’s $350 million to $400 million market. Within coming years, the company projects it could supply two-thirds of the domestic market, NorthStar officials said.

NorthStar now plans to add 20 people to its staff of 70 at its headquarters on Gateway Boulevard in Beloit, company officials told The Gazette during a recent interview. They said the company has plans in the near future to expand its 55,000-square-foot Beloit headquarters, starting in the coming weeks by setting up commercial production of its RadioGenix equipment there, along with other operations.

The company’s patented and now federally approved RadioGenix is the device NorthStar’s customers will use to separate moly-99 from technetium-99m. Technetium-99m is the radioactive material moly-99 naturally decays into. It’s the material used to illuminate bone, heart and body tissue in as many as 50,000 medical tests a day in the U.S. alone.

The RadioGenix devices are central to NorthStar’s business model. Through agreements with NorthStar, radiopharmacy customers would use RadioGenix units to handle moly-99 that NorthStar produces and packages in special, heavily insulated metal vessels the company also will manufacture.

Radiopharmacies must work through licensing processes to use NorthStar’s equipment, but some of NorthStar’s customers already are visiting the Beloit facility to train on RadioGenix devices NorthStar houses in Beloit, NorthStar President and Chief Operating Officer Stephen Merrick said. Some of those customers could begin getting NorthStar’s products shipped to them in the next several weeks, Merrick indicated.

Now, almost all the world’s moly-99 is made from highly enriched uranium in a few reactors outside the U.S. and is processed in four facilities worldwide, NorthStar officials said. Moly-99 now is shipped by airplane, sometimes making an 18-hour flight before it passes through just a few supplier companies in the U.S. on its way to medical use.

Because moly-99 is radioactive, it begins to decay within hours, which can make distant international distribution a logistical conundrum, NorthStar officials said. The supply chain also has seen interruptions and shortages of medical moly-99 in the last several years because some foreign reactors are aging and at times need to be shut down for regulatory reasons.

For those reasons, the U.S. government has pumped millions of dollars into programs and grants to help startup moly-99 producers such as NorthStar develop and get approval to produce and supply moly-99 domestically.

As NorthStar cracks the market with its RadioGenix, it would be the first domestic producer and direct supplier of moly-99. Its immediate bet would be that radiopharmacies would prefer to deal with NorthStar over foreign producers and the domestic suppliers who now separate Technetium-99m for foreign producers.

NorthStar is geared to compete directly with the domestic suppliers, Merrick said.

“We’re focusing on radiopharmacies,” Merrick said. “It’s a far bigger market than just being a business-to-business supplier of moly-99. I always use the analogy of a Keurig (single-brew coffee) machine. We make the Keurig machine (RadioGenix), we supply the coffee, and we put it in the pots so you can make your coffee.”

Beloit the ‘heart’ of moly-99?

Within the coming months, major parts of NorthStar’s processes—including manufacturing and distribution of moly-99 storage vessels and manufacture of RadioGenix devices—are expected to be handled in Beloit, although equipment manufacturing is launching now at a NorthStar facility in Madison.

Merrick said that work will roll out as NorthStar sets up equipment and completes a lesser, “supplemental” federal approval to handle equipment manufacturing in Beloit.

Other projects planned will over the next two or three years will transform the 33-acre parcel into a multi-building campus Merrick said could house all aspects of the company’s equipment manufacturing and some of its moly-99 production. NorthStar eventually plans to use particle accelerators to produce moly-99 at a facility to be built in Beloit, Merrick and NorthStar Chief Science Officer Jim Harvey said.

NorthStar now produces moly-99 using a reactor at the University of Missouri Research Reactor Center in Columbia, Missouri. The company would continue using the Missouri reactor to have multiple production operations, Harvey said.

Merrick said NorthStar plans a 20,000-square-foot expansion in Beloit to dissolve radioactive targets and fill insulated vessels with moly-99 solution. The Beloit facility already is set up and approved to be a distribution hub to handle moly-99 vessels coming and going from radiopharmacies, Merrick said. He said NorthStar also plans to develop a facility for recycling partially spent moly-99 material for reuse.

Merrick calls the Beloit campus the intended “heart” of NorthStar’s operations.

Messina and Merrick said production of moly-99 in Beloit could begin by about 2021, which could be months after its Rock County competitor, Janesville-based startup SHINE Medical Technologies, says it will begin producing its own moly-99 at a facility planned for Janesville’s south side.

SHINE has developed particle accelerator technology it would use in a production facility the company says could break ground later this year and be in operation by 2020.

But it appears NorthStar will be the first of the two Rock County companies to domestically produce and supply moly-99 in the U.S.

Immediately, NorthStar aims to hire about 20 more employees to staff its Beloit facility, bringing the company’s overall headcount to about 150 people. That would include about 90 employees in Beloit, 50 research and development staff at a NorthStar facility in Madison, and about 10 workers in Columbia, Missouri, Merrick said.

In Missouri, NorthStar now uses a method of making moly-99 called “neutron capture,” a process that involves a nuclear reactor firing neutrons into a molybdenum-98 target to produce molybdenum-99, all without the use of highly enriched uranium.

That’s different from moly-99 production methods scientists at foreign government reactors have used for years: a process that involves nuclear fission using highly enriched uranium—the same material that can be used to make nuclear weapons.

NorthStar’s process also differs from a method SHINE plans to use to make moly-99.

SHINE has said its accelerators would send a beam of ions into a gas target, inducing a reaction that produces neutrons. The neutrons would then hit a second target—a solution of low-enriched uranium—and induce fission, a process that would create moly-99 and other medically useful isotopes.

A moly-99 duel?

SHINE is now building a test and demonstration facility in Janesville that is expected to be operational sometime in 2018, the company has said.

In a news release last week, SHINE said that by summer 2018 the facility will house and demonstrate SHINE’s proprietary accelerator technology.

Earlier this month, SHINE Vice President Katrina Pitas waved away NorthStar’s move into the domestic moly-99 market, telling The Gazette in an email that NorthStar produces “low-specific-activity” moly-99—a type Pitas said would require pharmacy customers to adjust to “new and complex distribution equipment.”

Pitas wrote that SHINE aims to produce “high-specific-activity” moly-99, the kind now produced with foreign fission reactors. That’s the type of moly-99 she said the medical market has “long been served” by.

Pitas indicated it remains to be seen whether the market will want to “change behavior” and use a new type of distribution equipment geared for use with a different type of moly-99.

When asked about SHINE’s statements, Messina said the U.S. Food and Drug Administration approved NorthStar’s RadioGenix equipment because NorthStar proved it can separate the active medical isotope, technetium-99m, in a way that makes it “identical” to any technetium-99m now on the market—including types processed from foreign reactors and the type SHINE plans to produce.

“If you were to sit down and take a look at the same amount of (competitors’) technetium-99m and take a look at ours, it would be identical,” Messina said. “If you make a statement that our technetium-99m is somehow inferior to what’s on the marketplace today, that kind of insinuates that the end product, the (medical) image quality (it would provide), is going to be poorer. Which is a lie.”

Competitors might claim to be uninspired by NorthStar’s jump to market, but those who fund NorthStar’s development are unlacing their purse strings.

Messina told The Gazette this week that NorthStar recently landed about $27 million in new funding for its continued development, a development that hadn’t yet been announced. Along with facility buildouts in Beloit, NorthStar’s plans include further research and development and forays into production of more than a half-dozen isotopes that could be used to treat cancer and immune system diseases such as HIV, Messina said.

NorthStar didn’t disclose the sources of new funding, but Hendricks Holding Co., owned by Beloit business mogul Diane Hendricks, has been a major investor in NorthStar’s development.

“They’ve been remarkable to work with,” Messina said. “I mean, they funded the building here. They’re funding a building across (the way).”

Messina also gives credit to federal agencies, including the U.S. Department of Energy, the National Nuclear Security Administration, and the U.S. Food and Drug Administration, which have spent years and dedicated millions of dollars to run programs and regulatory processes aimed at bringing domestic moly-99 production to fruition.

“We really have been very fortunate to team up with people who have worked as hard as they’ve worked for us,” Messina said. “We’re very grateful for that.”


Local
Eighth-graders learn that garbage is easy and compost is difficult

JANESVILLE

It’s a good day when your teacher sends you outside for a bucket of mud.

This means something interesting is going to happen, something outside the routine of listening, note taking and testing repeated until graduation.

Across the Janesville School District, eighth-grade students are engaged in a new way of learning science—one that involves buckets of mud, thinking like a scientist and, perhaps, making their community a better place.

The students are a part of a study designed by professor Sadhana Puntambekar of UW-Madison’s Interactive Learning and Design Lab. The study, which is funded by a National Science Foundation grant, is called “Biosphere: Fostering Deep Learning of Complex Biology for Building Our Next Generation’s Scientists.”

It’s a daunting title, and a worrisome one, too, especially for those who remember eighth-grade science as a collection of abstract ideas that maybe didn’t apply immediately to the real world.

“The main premise on which my project is based is that science needs to be taught and learned as a connected (networked) body of knowledge rather than set of fragmented facts,” Puntambekar wrote in an email to The Gazette.

On a recent Thursday, the students in Craig Fischer’s classroom at Edison Middle School were making biospheres—miniature composters—out of 2- liter soda bottles.

Fischer laid down the law at the start of class.

“You only get two 2-liter bottles,” Fischer said. “If you do something wrong, you’re going to have to problem solve.”

The soda bottles were cut and then filled with a mixture of materials students chose. Available items include rotting, sprouting or expired food items the students brought from home; dead plant stems cut from Fischer’s yard; and, of course, the bucket of mud and dead leaves collected that morning.

All the ingredients were weighed and recorded in a data notebook. Students must also justify including a particular item.

Oranges cut and squeezed in the mixture added fluid to the mix, and the sugars might feed the other organisms working to break down the compost.

Sam Walters, 13, and his teammates decided to cut up potatoes to expose more of them to the air, bugs and other organisms that might be breaking it down.

Another boy was adding eggshells to his mix. The shells contain calcium, a macronutrient found in healthy soil. As the shells break down, they also help aerate the soil.

And soil is what it is all about.

The goal of the experiment is to find what combination of materials creates the most nutrient-rich soil in the shortest amount of time.

The experiment was one part of a longer study on the effect of garbage on the environment.

Americans generate 250 million tons of trash every year, and about 57 percent goes into municipal landfills, according to the teaching material for the study.

Between 20 percent and 40 percent of waste going into landfills is food scraps and yard trimmings.

The breakdown of garbage in landfills adds greenhouse gases to the atmosphere.

Food waste is an issue, too.

Earlier in their study, students did a garbage audit, saving all the trash they generated at lunch.

Photos of the collection showed a pile of food waste on a plastic tarp. It was competing with a mound of milk cartons and another of other food packaging.

Making the connections between the real world and school is a crucial, said Matt Peerenboom, assistant principal at Edison and head of the science curriculum committee. It’s the best way to keep kids engaged in academics.

In October, the Janesville School Board approved new set of five-year goals. One goal reads: “Teachers will increase/focus instruction from direct to engaged and empowered instructional opportunities.” Direct instruction means the teacher is in front of the classroom lecturing while the students listen and take notes.

Providing “engaged and empowered instructional opportunities” means students are doing the work of learning. It’s often hands on, involves working in groups and means students are given a problem to solve—with no instant answers from the teacher.

A sign in Fischer’s classroom describes the steps in scientific thinking: “Create, evaluate, analyze, apply and understand.”

That’s the way Fischer wants students to problem solve if they make a mistake; that’s part of science, too.

“Honestly, the biggest struggle is to stay patient for long enough to let the process take place,” Fischer said. “They have to let themselves be patient with the learning.”

Sometimes that means not coming to a definite answer—or when they do find an answer, having it lead to more questions, Fischer said.

One student complained that “Mr. Fischer never gives us the answer.”

Fischer admits that he does give students “guidance.” Last year, one kid put milk and chili into his composter, and it created a stench that no amount of Febreze would remove.

What do other students think?

“I like it,” Sam said. “It’s interactive, and it lets us get our hands dirty.”

Now where did that bucket of mud get to?


Maury Neipris/Nova Southeastern Athletic Communications 

Nova Southeastern junior Alison Hughes, a Janesville Craig High graduate, attempts a 3-point shot during a December game against Shaw in Fort Lauderdale, Fla. The 2015 Craig grad transferred to Nova Southeastern from the University of Minnesota-Crookston. She is one of the leading 3-point shooters in NCAA Division II competition. Story on Page 1B.


Few states let courts take guns from people deemed a threat

SACRAMENTO, Calif.

The warnings around Nikolas Cruz seemed to flash like neon signs: expelled from school, fighting with classmates, a fascination with weapons and hurting animals, disturbing images and comments posted to social media, previous mental health treatment.

In Florida, that wasn’t enough for relatives, authorities or his schools to request a judicial order barring him from possessing guns.

Only five states have laws enabling family members, guardians or police to ask judges to temporarily strip gun rights from people who show warning signs of violence. Supporters of these measures, deemed “red-flag laws” or gun-violence restraining orders, say they can save lives by stopping some shootings and suicides.

Florida, where Cruz is accused of using an AR-15 assault weapon to kill 17 people at his former high school, lacks such a law. He was able to legally own the semi-automatic rifle, even though his mother, classmates and teachers had at times described him as dangerous and threatening, and despite repeated police visits to his home.

Red-flag legislation has been introduced by Democratic state lawmakers, but it hasn’t been heard during this year’s session, and its fate is uncertain in a state Legislature controlled by Republicans who generally favor expanding gun rights.

After Wednesday’s shooting, Republican Gov. Rick Scott said he will work to make sure people with mental illnesses don’t have access to guns, but offered no specifics. Florida’s GOP Sen. Marco Rubio—facing withering criticism over his acceptance of $3.3 million in career campaign cash donated through the National Rifle Association—is going a step further now.

Rubio said on a Sunday morning show that state legislators should “absolutely” consider enacting a law enabling family members or law enforcement officials to ask a court to remove guns from a person who poses a danger. Rubio, who once served as Florida’s House speaker, told Miami CBS affiliate WFOR that it’s an “example of a state law” that could have helped prevent the Florida shooting.

In 2014, California became the first state to let family members ask a judge to take firearms from a relative who appears to pose a threat. Its Legislature took action after a mentally ill man, Elliot Rodger, killed six students and wounded 13 others near the University of California, Santa Barbara, before killing himself.

California’s law also empowers police to petition for the protective orders, which can require authorities to remove firearms for up to one year. Connecticut, Indiana, Oregon and Washington also have some version of a red flag law.

More than a dozen others, including Hawaii, New Jersey and Missouri, are considering bills to enable family members or police to petition the courts to take weapons away from people showing signs of mental distress or violence.

The Florida shooting has revived debate about whether teachers and school administrators should have that authority as well, given that people at Cruz’s high school witnessed much of his erratic behavior.

California lawmakers voted to expand their law in 2016 so that high school and college personnel, co-workers and mental health professionals can seek the restraining orders, but Gov. Jerry Brown called the effort premature and vetoed it.

State Assemblyman Phil Ting, a San Francisco Democrat, said he plans to reintroduce the bill.

“We need to make sure that when people see signs, they have every ability to do something about getting guns out of the hands of mentally ill and dangerous people,” Ting told The Associated Press.

Circumstances similar to those in Florida played out seven years ago in the shooting of Rep. Gabrielle Giffords in Arizona.

Jared Loughner had become increasingly disruptive and erratic at his community college in the months leading up to the shooting, frightening students and causing teachers to request campus police officers be on hand during his classes. Eventually, the school threatened him with suspension.

Soon after, he went to a gun store and legally bought the weapon he used to attack Giffords as she met with constituents, shooting her in the head and killing six people.

Without red flag laws, the main recourse available to family members is to have a troubled loved one committed to a psychiatric institution. Federal law permanently bans anyone who has been involuntary committed from owning guns, but such actions are more difficult to carry out than red-flag laws, which are intended to be quick and temporary and have a lower standard of proof.

Without such a commitment, formal adjudication of serious mental illness or a felony conviction, many people can pass background checks and possess guns they already own.

The red-flag laws act as a sort of timeout, so someone in psychological distress can get counseling while their fitness to possess a gun is evaluated, said Laura Cutilletta, legal director of the Giffords Law Center.

Many gun-rights activists oppose the laws. They say they can be used to unfairly take away rights from people who have not been convicted of crimes, nor professionally evaluated for mental illness.


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